Carefusion Corporation
FDA adverse event reports naming Carefusion Corporation as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: CAREFUSION CORPORATION.
- Total reports
- 3,843
- Deaths
- 52
- Injuries
- 596
- Malfunctions
- 3,175
Reports per year
Source: FDA adverse event reports by year received, 2009–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Set, Administration, IntravascularFPA2,548
- Pump, InfusionFRN1,177
- Pump, Infusion, PcaMEA47
- Filter, Infusion LineFPB19
- Ventilator, Continuous, Facility UseCBK17
- Container, Specimen, SterileFMH4
- Ventilator, Emergency, Manual (Resuscitator)BTM3
- Mixer, Breathing Gases, Anesthesia InhalationBZR3
- Nebulizer (Direct Patient Interface)CAF3
- Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK3
Recent recalls
- 2013-04-15TerminatedSoftware design
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached.
- 2013-04-15TerminatedSoftware design
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s
- 2013-03-28TerminatedDevice Design
Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.
The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.
- 2010-10-13TerminatedComponent design/selection
CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
Under certain wireless network conditions a communication error can occur, which freezes the PC Unit screen, which may result in a delay of therapy. A delay of therapy may result in serious injury and/or death. CareFusion identified this potential risk associated with the Alaris PC unit model 8015 only (PC Unit) manufactured between December-2008 and September-2009.
- TerminatedDevice Design
Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module
Than recall was initiated because CareFusion has identified identified a potential risk associated with the Alaris PC unit formerly known as Medley PC unit (PC Unit) model 8000 only when used with Alaris Pump module (Pump module) or Alaris Syringe module' (Syringe module), This recall notification details the potential risk and recommended steps for users to take if they encounter a specific PC
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